Associate Director/Director, Technical Operations and Development - REMOTE East Coast Based
About The Position
As Associate Director/Director, Technical Operations and Development, you will steer late-stage CMC execution for gene therapy programs, ensuring development and manufacturing activities are aligned with global regulatory expectations from Phase III through validation, submission, approval, and launch. Working fully remote on an Eastern schedule, you’ll move between focused technical reviews and collaborative decision-making. Your day may start by aligning on late-stage priorities with CMC peers, then shift to reviewing control strategy elements and data packages that support readiness for validation and filing. You’ll spend time translating emerging risks into practical options, clarifying what “good” looks like for documentation and traceability, and keeping stakeholders synchronized across time zones. As the day progresses, you’ll track progress against interim milestones, prepare concise updates for governance forums, and close out by confirming next steps with partners so teams can execute efficiently and compliantly.
Requirements
- Proven late-stage biotherapeutic CMC leadership through process validation, regulatory submission/approval, and market launch
- Strong GMP knowledge and experience supporting GMP biomanufacturing execution
Nice To Haves
- HSV and AAV gene therapy production experience
Responsibilities
- Lead cross-functional CMC planning across DP/DS, analytics, and MSAT, with clear milestones and progress reporting
- Define and implement analytical and manufacturing control strategies, including CQAs, CPPs, and specification/range setting
- Provide technical leadership to resolve complex testing, processing, and manufacturing challenges in regulated environments
- Partner with internal and external stakeholders to maintain alignment between program strategy and CMC deliverables
Benefits
- Medical, dental, and vision coverage
- 401(k)
- life insurance
- Health Savings Account (HSA) and Flexible Spending Account (FSA) options
- paid time off
- employee discounts
- employer-paid short-term and long-term disability (STD & LTD)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
